Egg Freezing Pilot Study | NCT00839839

Studies
Egg Freezing Pilot Study

NCT00839839

Sponsor

University Reproductive Associates

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Infertility
Egg Freezing

Interventions

Oocyte Vitrification

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Feb 9, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter McGovern, MD, Principal Investigator, University Reproductive AssociatesPrincipal Investigator

Lead Sponsor

University Reproductive AssociatesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oocyte Vitrification	Experimental		Procedure: Oocyte Vitrification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oocyte Vitrification	Procedure	All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Biochemical Pregnancy		1 year

Secondary Outcomes

Measure	Description	Time Frame
Recovery of viable oocytes		1 year
incidence of fertilization		one year
embryo development (how many fertilized eggs undergo development to a more advanced stage)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
In good general health off of current medications which may confound response to study medications.
Desire to seek pregnancy actively during the study period by IVF-ICSI.
A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
Ability to use the required medications.
Day 3 FSH level < 12 IU/ml

Exclusion Criteria:

Current pregnancy
Patients with significant anemia (Hemoglobin < 10 mg/dL).
Patients enrolled simultaneously into other investigative studies that would interfere with this research study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter G. McGovern, MD	UMDNJ-NJMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Reproductive Associates		Hasbrouck Heights	New Jersey	07604	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided